Coodley Gregg O.; Nelson, Heidi D.; Loveless, Mark O.; Folk, CathiJournal of Acquired Immune Deficiency Syndromes: March 1993 CLINICAL SCIENCE: PDF Only Free Abstract β-Carotene has been reported to have an immunostimulatory effect. Recent studies suggest that (β-carotene supplementation can increase CD4 counts in HIV-infected patients. Our double-blind, placebo-controlled clinical trial was designed to test the efficacy of p-carotene in raising CD4 counts in HIV-infected patients. Twenty-one HIV-seropositive patients were randomized to receive either β-carotene, 180 mg/day or placebo for 4 weeks, and then crossed over to receive the alternative treatment for the following 4 weeks. β-Carotene resulted in a statistically significant increase in total WBC count (p = 0.01). % change in CD4 count (p = 0.02), and % change in CD4/CD8 ratios (p = 0.02) compared to placebo. The absolute CD4 count, absolute CD4/CD8 ratio, and total and B-lymphocytes all increased on carotene and fell during placebo, but these differences did not reach statistical significance. No toxicity was observed on either treatment. p-Carotene appears to have an immunostimulatory effect in HIV-infected patients. Further studies are needed to demonstrate whether β-carotene has a role as adjunct therapy in treatment of HIV-infected patients. © Lippincott-Raven Publishers.